Kornimate/medical-research-clean huggingface dataset:
clinical study of stent versus direct atherectomy versus angioplasty to treat lower limb in-stent restenosis

Conditions: Atherosclerosis; In-stent Arterial Restenosis

Summary: this is a randomized study comparing stent versus direct atherectomy versus angioplasty to treat lower limb in-stent restenosis (superficial femoral or popliteal artery).

this is a randomized study comparing stent versus direct atherectomy versus angioplasty to treat lower limb in-stent restenosis (superficial femoral or popliteal artery).

Eligibility criteria:
inclusion criteria: provides written informed consent willing to comply with follow-up evaluations at specified times has claudication or rest pain due to peripheral arterial in-stent restenosis disease located within the femoropopliteal artery patient has a in-stent restenosis lesion(s) with \>50% stenosis documented angiographically patient has symptoms of peripheral arterial disease classified as rutherford category 2 or greater. exclusion criteria: they were excluded if they had one or more of the following: 1. acute or subacute lower limb ischemia; 2. severe calcification lesions; 3. total occlusions lesions more significant than 10 cm or total occlusion lesions with a suspicion of subintimal wire recanalization 4. untreated ipsilateral iliac artery stenosis\>70%, or the distal runoff artery \<1 root; 5. previously lower extremity intervention or surgical graft artery bypass; 6. severe renal insufficiency, creatinine level greater than 2.5 mg/dl; 7. the patient's platelet count is less than 100,000/ul, antiplatelet or anticoagulant contraindications to required medications; 8. patients with immune system diseases or malignant tumours; 9. ongoing active infection 10. decompensated congestive heart failure or acute coronary syndrome; 11. unwillingness to return for future follow-up visits

Keywords: stents atherectomy femoral artery popliteal artery in-stent restenosis
effects of cervical spine manipulation on gait

Conditions: Cervicalgia

Summary: the purpose of the study is to see if manipulation of the neck will change the way people who may or may not have neck pain, walk under differing conditions.

volunteers in this study will be asked to do the following: 1) complete a series of questionnaires about health status and undergo physical screening of neck to make sure that manipulation will not be harmful; 2) walk in socks or bare feet across a computerized mat under 3 conditions - normal walking pace, walking while looking up and down repeatedly; and walking while looking left and right repeatedly; 3) have one of 2 manual therapy interventions to the neck; 4) repeat the walking across the computerized mat under those same 3 conditions. the 2 randomly assigned interventions are: cervical manipulation, or cervical contact. if assigned the manipulation, volunteers will lie face up and the trained therapist will move the joints in the neck in a gentle, but short and sharp manner which may produce a slight 'pop' or 'click'. if volunteers are assigned the cervical contact, they will lie on their back and the trained therapist will gently hold the head and neck for 45 to 60 seconds as they quietly relax.

Eligibility criteria:
inclusion criteria: 1. volunteers may or may not have mechanical neck pain 2. aged 18 to 70 years 3. if neck pain is present, must have neck disability index score of at least 10 out of 50 points exclusion criteria: 1. 'red flag' items indicated in neck medical screening questionnaire such as history of a tumor, bone fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc. 2. history of neck whiplash injury 3. diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms 4. presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes 5. evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck) 6. prior surgery to neck or upper back 7. a medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency) 8. diagnosis from your physician of fibromyalgia syndrome 9. currently pregnant, or could be pregnant

Keywords: cervicalgia
drug-drug interaction study between fluconazole and edp-938 in healthy subjects

Conditions: RSV Infection

Summary: a non-randomized, open-label, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of edp-938 in healthy subjects


Eligibility criteria:
inclusion criteria: * inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 90 days after the last dose of edp 938. exclusion criteria: * clinically relevant evidence or history of illness or disease * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * participation in a clinical trial within 30 days prior to the first dose of study drug. * clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals

Keywords: drug-drug interaction
vagal response and cardiac autonomic modulation. insides from cryoballoon ablation

Conditions: Vagal Nerve Stimulation; Autonomic Nervous System; Catheter Ablation

Summary: the investigators sought to evaluate the incidence and influence of vagal response observed during cryoballoon-based pulmonary vein isolation on the cardiac autonomic nervous system (cans) and ablation outcomes in paroxysmal atrial fibrillation cohort. 296 patients were treated with a 28-mm second-generation cryoballoon (arctic front advance, medtronic). preprocedural pulmonary veins anatomy and their ostial dimensions were acquired with a computed tomography. 74 patients without structural heart disease and with no concomitant diseases were chosen for a detailed cans assessment with heart rate variability analysis. all patients were screened over a 2-year post-ablation period.

an interplay between left atrial (la) ganglionated plexi (gp), a part of the intrinsic cardiac autonomic nervous system (cans), and pulmonary veins (pvs) is considered to be an important mechanism related with the initiation and maintenance of atrial fibrillation (af). therefore additional gp ablation has been reported with better ablation outcomes when added to rf-based pv isolation (pvi). a cryoballoon ablation (cba) is an anatomically based approach which allows pvi that is highly safe and efficacious. the extension of the scar created by the cryoballoon frequently extends beyond the pv orifice in the acute and chronic post-ablation phase creating a set of lesions that are near the la-gp area and inadvertent damage. a marked vagal response (vr) observed during cba is considered a marker for the cans modification. however, changes in the autonomic tone were independently noted from the presence of vr in several studies. moreover, it is not clear if these changes are transient or long-lasting, and it has been shown that the presence of vr increases ablation success although with conflicting results. in previous studies assessing the influence of cba on the autonomic balance, cans modulation was appraised with different surrogates, a small number of individuals were usually recruited and both paroxysmal and persistent af populations were included. therefore, the investigators sought to evaluate the incidence of vr observed during cba-based pvi, its impact on cans assessed with widely accepted heart rate variability (hrv) analysis, and in relation to ablation outcomes in a large paroxysmal af (paf) cohort.

Eligibility criteria:
inclusion criteria: * diagnosis of paroxysmal atrial fibrillation exclusion criteria: * previous atrial fibrillation ablation

Keywords: atrial fibrillation cardiac autonomic nervous system cryoballoon ablation ganglionated plexi heart rate variability vagal response
clearance of nnal and cotinine from second-hand smoke in hair and urine

Conditions: Lung Cancer

Summary: this study will investigate how long it takes for nnal and cotinine, markers of second hand smoke, to clear the human body.

the purpose of the study is to investigate how long it takes for nnal and cotinine, both specific markers of second hand tobacco smoke exposure to clear the human body.

Eligibility criteria:
inclusion criteria: * healthy caucasians and african-americans 19 years of age or above, how are ready to quit smoking exclusion criteria: * anyone who is not a caucasian or an african-american, below 19 years of age, and is currently taken prescription medication.

Keywords: nnal cotinine second hand smoke
influence of culture media on clinical outcomes in poor responders or severe male infertility

Conditions: Poor Responder; Severe Male Infertility; Embryo Development; Blastocyst; Culture Media

Summary: in this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. the aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. the study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching ivf treatments with a diagnosis of oat, cryptozoospermia, advanced maternal age and women with a "poor responder" diagnosis were recruited. ivf treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.

the final goal in the field of assisted reproductive technology is to obtain a single healthy newborn. for that purpose, a lot of factors are strictly interconnected each other's and have to be carefully evaluated. the choice of embryo culture system and of embryo selection strategy plays a crucial role in obtain and identify the embryo with the highest implantation potential. one really important key factor is the choice of the culture media. currently, there are numerous commercially available culture media showing very different compositions. essentially two strategies have been applied for the design of culture media: 1) "back to nature" for sequential media, based on the physiology of the embryo and the measured concentration of substances present in its natural environment and 2) "let the embryo choose" for single step media, where none a priori assumption of the concentration of a component is made. in the literature, there are a lot of studies analyzing the effect of culture media on human preimplantation embryos development and comparing biological and clinical outcomes among different media compositions. several studies performed a comparison about the development of human zygotes in either a one-step or two-step culture system. usually there were no significant differences between the two culture media systems regarding biological or clinical outcomes. anyway, a greater number of blastocysts were generally obtained by the continuous single medium culture if compared with sequential culture media, even if the implantation and clinical pregnancy rates are comparable.

Eligibility criteria:
inclusion criteria: * advanced maternal age, * poor responder women (\<=4 oocytes), * cryptozoospermia, * testicular retrieval of spermatozoa exclusion criteria: * any other

Keywords: media blastocyst male infertility poor responders pgs
an observational registry to evaluate the incidence of and risk factors for vascular occlusive events associated with iclusig®

Conditions: Myeloid Leukemia, Chronic-Phase, Accelerated-Phase, Blast-Phase, Ph+ALL

Summary: this is an observational registry to further characterize the safety profile of patients with chronic myeloid leukemia in the chronic phase (cp-cml), accelerated phase (ap-cml), blast phase (bp-cml), or ph+all treated with iclusig (ponatinib) in routine clinical practice in the us. the registry is focused on analysis of vascular occlusive events.

the registry is being conducted in an effort to better understand rates, risk factors, and outcomes associated with vascular occlusive events in patients treated with iclusig (ponatinib) in real world settings. this registry study will collect information about patient demographics, leukemia diagnosis, previous anti-cancer treatments, history of cardiovascular disease, risk factors for vascular complications, and concurrent medications (including antiplatelet and/or anticoagulant agents).

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥18 years) who are diagnosed with cp-cml, ap-cml, bp-cml, or ph+ all 2. patients who are initiating iclusig therapy for the first time, or for whom iclusig therapy was initiated within 30 days before registry enrollment. 3. the decision to prescribe iclusig must have been made prior to enrollment in the registry and based upon approved us indications. 4. patients who have the ability to understand the requirements of the registry, and provide written informed consent to comply with the registry data collection procedures. exclusion criteria: 1. patients previously treated with investigational iclusig. 2. patients receiving any investigational agent (eg, any drug or biologic agent or medicaldevice that has not received approval in the us) or receiving iclusig for any indication not currently approved in the us. 3. concurrent treatment with another tki.

Keywords: leukemia leukemia, myeloid leukemia, myelogenous, chronic, bcr-abl positive ponatinib pharmacologic actions protein kinase inhibitors risk factor leukemia, myelogenous, chronic cml cp-cml iclusig ap24534 ap-cml bp-cml ph+all
bacillus cereus infection of patients diagnosed at nîmes university hospital

Conditions: Bacillus Cereus Infection

Summary: objectives: we aimed to study the characteristics of patients presenting with a bacillus cereus infection in a university hospital. methods: we performed a retrospective analysis of the clinical, biological, and treatment-related data of patients hospitalized in our university hospital between january 1st, 2008 and december 31st, 2012 and diagnosed with a b. cereus infection. we identified a subgroup of patients presenting with bacteremia and looked for risk factors for death within that group of patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with a b. cereus infection * patients adult (\>18) exclusion criteria: * patientn diagnosed without infection by b. cereus
a long-term study of adynovi/adynovate in participants with haemophilia a

Conditions: Hemophilia A

Summary: the main aim of this study is to check for long-term side effects from adynovi/adynovate prophylaxis in participants with haemophilia a when used under standard clinical practice in the real-world clinical setting.


Eligibility criteria:
inclusion criteria * signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol). * participant at any age with haemophilia a prescribed adynovi/adynovate prophylaxis. * negative factor viii (fviii) inhibitor test at study entry. * decision to initiate treatment with commercially available adynovi/adynovate has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study. exclusion criteria * previous participation in this study. participation is defined as signed informed consent. * known or suspected hypersensitivity to adynovi/adynovate or related products. * mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
combination therapy of omalizumab and allergen immunotherapy for moderate to severe asthma

Conditions: Allergic Asthma

Summary: the combined treatment of anti-ige monoclonal antibody and standardized allergen immunotherapy has good efficacy and safety in allergic diseases. however, the efficacy and safety of the combined treatment for allergic asthma in the chinese population have not been fully elucidated yet.this study is a prospective observational study designed to evaluate the efficacy and safety of omalizumab combined with allergen immunotherapy (ait) in patients with moderate to severe asthma in the chinese population.


Eligibility criteria:
inclusion criteria: individuals who meet all of the following criteria are eligible for enrollment as study participants: 1. chinese patients,aged 6 years and older，female or male 2. diagnosed as allergic asthma according to the guideline for chinese guidelines for the diagnosis and treatment of allergic asthma（2019，the first edition） 3. meet the diagnostic criteria for moderate and severe asthma, in line with the diagnostic standards of the gina (global initiative for asthma)，it refers to those who can achieve complete control under the gina step 3 treatment; for severe asthma, it refers to those who need step 4 or step 5 treatment to achieve complete control, or those who still cannot achieve control even after undergoing step 4 or step 5 treatment. 4. the patients included in the study were positive for specific immunoglobulin e (sige), or had a positive skin prick test (spt) with d.pteronyssinus and d. farinae allergens. 5. patients who will initiate ait or omalizumab combined with ait according to real life clinical standards of practice. exclusion criteria: individuals who meet any of the following criteria are not eligible for enrollment as study participants: 1. uncontrolled asthma or forced expiratory volume in one second (fev1) is lower than 70% of the predicted value. 2. currently receiving treatment of beta blockers or angiotensin converting enzyme inhibitor (acei) 3．with severe or uncontrolled cardio-cerebral vascular, hepatic, renal, gastrointestinal, hematopoietic，genitourinary, endocrine, nervous and immunological medical conditions, or other conditions that investigators think the patient not suitable for this study. 4．pregnant or planning pregnancy.

Keywords: allergic asthma, ige, immunotherapy, omalizumab
impact of exercise training on single ventricle function in paediatric fontan patients

Conditions: Univentricular Heart

Summary: the goal of this observational study is to learn about how a prescribed exercise training program would affect children living with a fontan circulation. from birth, the children who are born with single functioning ventricle will undergo 3-staged fontan surgery to achieve a unique fontan circulation, supported by one functioning ventricle. with advancement in surgical technique and medical care, there are increasing number of children living with fontan circulating surviving into adulthood. a significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life. exercise training is a well-established therapy used in adult population with heart failure. it has been shown to be safe in children with congenital heart disease and with fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes. the main question\[s\] it aims to answer are the impact of a exercise training program on: 1. single ventricle function 2. exercise capacity 3. self-perceived quality of life 4. skeletal muscle mass participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. the following tests will be performed prior to starting and upon completion of the exercise program: * echocardiogram * cardiopulmonary exercise test * body composition scan using a bio-impedance analyser * quality of life questionnaires


Eligibility criteria:
inclusion criteria: * patients with fontan circulation, age range 8 to 18 years * ability to perform a cardiopulmonary exercise stress test (cpet) * free from acute or chronic respiratory illness and/or conditions that might affect exercise performance * who have had a fontan operation at least six months prior. exclusion criteria: * existing neuro-disability i.e. with paresis post cerebrovascular accident * neurodevelopmental issue with inability to comply with commands. * documented life-threatening arrhythmia without implantable cardioverter defibrillator * moderate or severe atrio-ventricular valve regurgitation * moderate or severe ventricular dysfunction by echocardiography exams * acute inflammatory cardiac disease * documented coronary artery stenosis and/or myocardial ischaemia * heart failure requiring hospitalisation in the past year * evidence of systemic venous pathway obstruction by echocardiography or catheterisation * resting oxygen saturation \< 90% * systemic ventricular outflow tract stenosis with peak resting systolic gradient \> 50mmhg

Keywords: fontan exercise training ventricular function quality of life
effect of tdcs on brain organization and motor recovery

Conditions: Stroke

Summary: neurological deficits and motor disorders are extremely common after stroke. physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. complementary therapies that could improve recovery would therefore be very welcome. transcranial direct current stimulation (tdcs) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. an increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. however, the "optimum" configuration of tdcs and the induced effects remain to be characterized and investigated. the investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tdcs setup. the optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke * ≤ 4 weeks after stroke onset * paresis of upper limb with fugl-meyer score between 15 and 55 at study entry * capable of participating during treatment sessions of 30-60 minutes * informed consent obtained exclusion criteria: * incapacity to understand study information or task instructions during trial. * new additional stroke during rehabilitation * reduced vigilance or delirium * severe language deficits * preexisting affection of an upper limb * severe spasticity or dystonia * severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease) * pregnancy * pacemaker * skull breach * history of seizures or epilepsy * metallic object in the brain * other contraindication to non-invasive brain stimulation